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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
August 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
- 4 instead of 3 animals
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol
EC Number:
609-222-8
Cas Number:
3625-82-9
Molecular formula:
C20 H28 O2
IUPAC Name:
3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control.
Amount / concentration applied:
0.1 ml (corresponded to 61.6 - 62.9 mg test material)
Duration of treatment / exposure:
test substance remained in the eye (eye was not rinsed)
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
2 males and 2 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.08
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.59
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.42
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Local findings after single administration of ZK 46060 into the conjunctival sac of the rabbit eye were slight to moderate reddening of the conjunctivae observed in all animals on administration day up to day 3 (except animal no. 359M only until day 2). Slight to moderate swelling of the conjunctivae was observed in all animals on administration day up to day 2 or 3. In addition, one male and one female animal showed vessel injection of the iris on administration day. The same finding was also observed in the other male animal but only on day 2. All animals were without findings on day 4.

Any other information on results incl. tables

Table 1: Results of the study

    

 Irritant effects (score)         

Animal no. (sex)

 Irritation parameter

 24 h 48 h  72 h  Mean scores

 1 (M)

 Cornea

 0 0  0  0.0
 

 Iris

 1 0 0 0.33
 

 Conjunctiva (reddening)

 1 1 0 0.67
 

 Conjunctiva (swelling)

  1 0 0 0.33

 2 (M)

 Cornea

 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 1 0 0.67
   Conjunctiva (swelling) 2 0 0 0.67

 3 (F)

  Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 1 0 0.67
   Conjunctiva (swelling)  1  1 0 0.67

 4 (F)

  Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1  1 0 0.67
   Conjunctiva (swelling) 0 0 0 0.0

The control eyes were without findings.

Local findings after single administration of ZK 46060 into the conjunctival sac of the rabbit eye were slight to moderate reddening of the conjunctivae observed in all animals on administration day up to day 3 (except animal no. 359M only until day 2). Slight to moderate swelling of the conjunctivae was observed in all animals on administration day up to day 2 or 3. In addition, one male and one female animal showed vessel injection of the iris on administration day. The same finding was also observed in the other male animal but only on day 2. All animals were without findings on day 4.

Applicant's summary and conclusion

Executive summary:

A single conjunctival administration into the conjunctival sac of the rabbit eye (OECD TG 405) provoked slight to moderate irritation which was fully reversible on day 4 after administration.